We ensure that all regulatory requirements are in place. In Portugal, we support the full submission and report to all three Portuguese regulatory entities responsible for assessing either an investigational medicinal product (IMP) or a medical device (MD).
Our team addresses all concerns that may exist and helps find adequate solutions in the framework of the national and local regulations, ensuring full compliance and an efficient communication between Sponsor, CRO, Study Sites and Regulatory Authorities throughout all stages of the clinical study.
We give support in the following tasks:
- Clinical Trial Authorization Form;
- Elaboration or Translation and adaptation of study documents (e.g. Informed Consent Form, product labelling, participant materials, etc);
- Study sites’ regulatory diligences;
- Complete submission to the Portuguese Authorities;
- Study Submission at site level (Local Ethics Committee/Board of Directors), for non-interventional studies;
- Substantial amendment preparation and submission;
- All regulatory notifications required;
- Pharmacovigilance – immediate and periodic safety notifications;
- Regulatory Advisory.
For further information or to get a quote this service, contact us.